Quality Specialist

When joining Perkin Elmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centres, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and One Source services.

We are seeking a highly organised & detail orientated Quality Specialist to join our team based on a customer site in the north of the UK, for the fixed-term contract (14 months). The role will form part of our on-site Quality team ensuring that our service delivery remains in compliance with our agreed quality commitments and regulatory requirements and quality management system.

* Fixed term contract 14 months*

• As part of the onsite team, provides routine support and guidance to ensure service delivery is in compliance to our agreed quality and regulatory standards
• Working with identified SME’s, supports with the writing of technical documentation ensuring high quality content and adherence to GMP standards.
• Provides guidance for the inspection readiness program for the site, while ensuring compliance to our scope of work and defined requirements within the QMS and Quality agreement.
• Inspection readiness may include periodic Perkin Elmer or client self-inspections, or any external agency inspections
• Works with the quality team and operations team providing support to the deviation, change, event & root cause investigation processes, ensuring effective and on-time completion of CAPA management.
• Support the vendor management program for the site to ensure adequate supplier compliance, while ensuring adherence to the QMS for the scope of work defined in the SLA and/or Quality Agreement.
• Develop and implement training and education programs, to educate PKI employees and management on quality processes, standards and results
• Support with the development and implementation of an annual quality plan based upon areas for continuous improvement of our quality service.
• Work closely with procurement, engineering and other departments to ensure supplier-related quality issues are addressed promptly.
• Participate in cross functional teams to drive quality improvement initiatives.
• Prepare and present reports on quality performance and audit findings to management.
• Support with the delivery of the program quality improvement plan

• Excellent analytical, problem-solving, and organisational skills.
• Strong communication and interpersonal skills
• Strong understanding of Good Documentation Practices
• Understanding of regulations governing GMP/GLP/GCP activities

• Bachelors degree in quality management, supply chain management or a related field OR Minimum of 3 years experience in quality assurance, supplier management, or a related role. OR Recognised Quality management related qualification OR Strong knowledge of quality standards and methodologies (e.g. ISO 9001, Six sigma, LEAN)

• Certified quality auditor or similar certification
• Knowledge of regulatory requirements relating to GMP
• Experience of working within Pharma

Role is site based on a customer site. Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory. Must be able to remain in a stationary position more than 25% of the time The person needs to…